- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07299513
Aerodigestive Fistulas in Adults at the University Hospital of Strasbourg (FAD'HUS)
Aerodigestive Fistulas in Adults: Management at the Strasbourg University Hospital Between 2014 and 2023
Acquired aerodigestive fistulas in adults are rare conditions, corresponding to a pathological communication between the digestive and respiratory tracts, requiring collaborative multidisciplinary management. Clinical manifestations are nonspecific, ranging from a simple cough to pulmonary sepsis, which can be life-threatening. Diagnosis is often multimodal, requiring radiological examinations and endoscopic investigations. The most frequent etiologies are divided into two groups: benign and malignant causes, each group representing 50% of all acquired aerodigestive fistulas. Among the benign etiologies, 75% are iatrogenic, mainly represented by complications related to orotracheal intubation. These fistulas of benign etiology most often have a favorable prognosis, amenable to surgical treatment. Conversely, the development of an aerodigestive fistula in the context of thoracic cancer marks a turning point in the evolution of the oncological disease. Indeed, the average life expectancy of patients with a malignant fistula is estimated at between 1 and 6 weeks without specific treatment. Following this palliative approach aimed at improving quality of life, multiple treatment options are available, often combined with digestive and thoracic endoscopy.
The Strasbourg University Hospitals are a leading tertiary care center for these pathologies, with departments of Pulmonology, Gastroenterology, Digestive Surgery, Thoracic Surgery, Medical Intensive Care, Multipurpose Surgical Intensive Care, Bronchial Endoscopy, and Digestive Endoscopy. The centre's influence extends over the entire eastern part of the Grand Est region (Nancy, Metz, Strasbourg, Mulhouse).
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Guillaume PAMART, MD
- Phone Number: 33 3/69/55/06/48
- Email: guillaume.pamart@chru-strasbourg.fr
Study Locations
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Strasbourg, France, 67091
- Recruiting
- Service de Pneumologie - Hôpitaux Universitaires de Strasbourg
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Sub-Investigator:
- Julien GODET, Statistician
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Contact:
- Guillaume PAMART, MD
- Phone Number: 33 3/69/55/06/48
- Email: guillaume.pamart@chru-strasbourg.fr
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Principal Investigator:
- Guillaume PAMART, MD
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Sub-Investigator:
- Arnaud SIEGEL, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years at diagnosis
- Diagnosis between January 1, 2014, and December 31, 2023
- Aerodigestive fistula defined by one of the following criteria:
- Fistula visualized by bronchoscopy and/or digestive endoscopy
- Fistula visualized by static chest imaging (CT scan or MRI)
- Fistula visualized by dynamic chest imaging (barium swallow)
- Hospitalization at the Strasbourg University Hospitals (HUS)
Exclusion Criteria:
- Explicit refusal by the patient to provide their data
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Overall survival rate since diagnosis
Time Frame: Up to 2 years
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Up to 2 years
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 9376
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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